Purevax RCCh
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
23-01-2015
Karatteristiċi tal-prodott
(SPC)
23-01-2015
Rapport ta 'Valutazzjoni Pubblika
(PAR)
22-01-2015
Ingredjent attiv:
attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains), attenuated Chlamydophila felis (905 strain)
Disponibbli minn:
Merial
Kodiċi ATC:
QI06AH
INN (Isem Internazzjonali):
vaccine against feline viral rhinotracheitis, feline calicivirosis and feline Chlamydophila infections
Grupp terapewtiku:
Cats
Żona terapewtika:
Immunologicals for felidae,
Indikazzjonijiet terapewtiċi:
Active immunisation of cats aged 8 weeks and older:against feline viral rhinotracheitis to reduce clinical signs;against calicivirus infection to reduce clinical signs and excretion;against Chlamydophila felis infection to reduce clinical signs.Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and Chlamydophila felis components.The duration of immunity is 1 year after the last (re-)vaccination.
Sommarju tal-prodott:
Revision: 8
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2005-02-22
Fuljett ta 'informazzjoni
Medicinal product no longer authorised
B. PACKAGE LEAFLET
14
Medicinal product no longer authorised
PACKAGE LEAFLET FOR:
PUREVAX RCCH
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
:
MERIAL
29, avenue Tony Garnier
F-69007 Lyon
France
Manufacturer for the batch release
:
MERIAL
Laboratoire Porte des Alpes
Rue de l'Aviation
F-69800 Saint Priest
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax RCCh
Lyophilisate and solvent for suspension for injection.
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Per dose of 1ml:
LYOPHILISATE:
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain)
......................................
≥
10
4.9
CCID
50
1
Inactivated feline Calicivirosis antigens (FCV 431 and FCV G1 strains)
.....................
≥
2.0 ELISA U.
Attenuated
_Chlamydophila felis_
(905 strain)
....................................................................
≥
10
3.0
EID
50
2
EXCIPIENT:
Gentamicin, at
most..........................................................................................................................
28 µg
SOLVENT:
Water for injection
.......................................................................................................................
q.s. 1 ml
1
: cell culture infective dose 50%
2
: egg infective dose 50%
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 and excretion,
_ _
-
_against Chlamydophila felis_
infection to reduce clinical signs.
15
Medicinal product no longer authorised
Onsets of immunity have been demonstrated 1 week after primary
vaccination course for
rhinotracheitis, calicivirus and
_Chlamydophila felis_
components.
The duration of immunity is 1 year after the last (re-)vaccination.
5.
CONTRAIND
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
Medicinal product no longer authorised
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax RCCh lyophilisate and solvent for suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 1 ml
LYOPHILISATE:
ACTIVE SUBSTANCES:
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain)
......................................
≥
10
4.9
CCID
50
1
Inactivated feline Calicivirosis antigens (FCV 431 and G1 strains)
..............................
≥
2.0 ELISA U.
Attenuated
_Chlamydophila felis_
(905 strain)
....................................................................
≥
10
3.0
EID
50
2
EXCIPIENT:
Gentamicin, at
most..........................................................................................................................
28 µg
SOLVENT:
Water for injection
.......................................................................................................................
q.s. 1 ml
1
: cell culture infective dose 50%
2
: egg infective dose 50%
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats.
4.2
INDICATIONS FOR USE
Active immunisation of cats aged 8 weeks and older:
-
against feline viral rhinotracheitis to reduce clinical signs,
-
against calicivirus infection to reduce clinical signs and excretion,
_ _
-
_against Chlamydophila felis_
infection to reduce clinical signs.
Onsets
of
immunity
have
been
demonstrated
1
week
after
primary
vaccination
course
for
rhinotracheitis, calicivirus and
_Chlamydophila felis_
components.
The duration of immunity is 1 year after the last (re-)vaccination.
4.3
CONTRAINDICATIONS
Do not use in pregnant animals.
The use is not recommended during lactation.
2
Medicinal product no longer authorised
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use only in healthy animals.
SPECIAL PRECAUTION
Aqra d-dokument sħiħ
