Purevax RCP FeLV
Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Uputa o lijeku
(PIL)
07-04-2022
Svojstava lijeka
(SPC)
07-04-2022
Izvješće o ocjeni javnog
(PAR)
10-03-2021
Aktivni sastojci:
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)
Dostupno od:
Boehringer Ingelheim Vetmedica GmbH
ATC koda:
QI06AH10
INN (International ime):
Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline leukaemia
Terapijska grupa:
Cats
Područje terapije:
Immunologicals for felidae,
Terapijske indikacije:
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 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 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 feline leukaemia component, and one year after primary vaccination course and three years after the last re-vaccination for the rhinotracheitis, calicivirosis and panleucopenia components.
Proizvod sažetak:
Revision: 15
Status autorizacije:
Authorised
Datum autorizacije:
2005-02-23
Uputa o lijeku
15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET:
PUREVAX RCP 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 RCP 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 feline panleucopenia virus (PLI IV)
.............................................
≥
10
3.5
CCID
50
1
EXCIPIENT:
Gentamicin, at most
..........................................................................................
23 µg
SOLVENT:
ACTIVE SUBSTANCE:
FeLV recombinant canarypox virus (vCP97)
..................................................
≥
10
7.2
CCID
50
1
.
1
cell culture 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 feline panleucopenia to prevent mortality and clinical signs,
-
against leukaemia to prevent persistent viraemia and clinical signs of
the related disease.
17
Onsets of immunity:
-
Rhinotracheitis, calicivirus and panleucopenia components: 1 week
after primary vaccination
course.
-
Feline leukaemia component : 2 weeks after primary vacc
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Svojstava lijeka
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax RCP FeLV 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 feline panleucopenia virus (PLI IV)
.............................................
≥
10
3.5
CCID
50
1
EXCIPIENT:
Gentamicin, at most
..........................................................................................
23 µg
Solvent:
ACTIVE SUBSTANCE:
FeLV recombinant canarypox virus (vCP97)
..................................................
≥
10
7.2
CCID
50
1
1
cell culture 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 feline panleucopenia to prevent mortality and clinical signs,
-
against leukaemia to prevent persistent viraemia and clinical signs of
the related disease.
Onsets of immunity:
-
Rhinotracheitis, calicivirus and panleucopenia components: 1 week
after primary vaccination
course.
-
Feline leukaemia component: 2 weeks after primary vaccination course.
Duration of immunity:
-
Rhinotracheitis, calicivirosis and panleucopenia components: 1 year
after primary vaccination
course and 3 years after the last re-vaccination.
-
Feline Leukaemia component: 1 year after the last re-vaccination.
3
4.3
CONTRAINDICATIONS
None.
4.4
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