Purevax RCPCh FeLV Lyophilisate and Solvent for Suspension for Injection

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Nunua Sasa

Tabia za bidhaa Tabia za bidhaa (SPC)
31-10-2023

Viambatanisho vya kazi:

Chlamydophila felis, Feline calicivirus, Feline leukemia virus, Feline panleukopenia virus, Feline viral rhinotracheitis virus

Inapatikana kutoka:

Boehringer Ingelheim Vetmedica Gmbh

ATC kanuni:

QI06AJ05

INN (Jina la Kimataifa):

Chlamydophila felis, Feline calicivirus, Feline leukemia virus, Feline panleukopenia virus, Feline viral rhinotracheitis virus

Dawa fomu:

Powder and solvent for suspension for injection

Dawa ya aina:

POM-V - Prescription Only Medicine – Veterinarian

Kundi la matibabu:

Cats

Eneo la matibabu:

Vector Vaccine

Idhini hali ya:

Authorized

Idhini ya tarehe:

2005-02-22

Tabia za bidhaa

                                Revised: March 2023
AN:
00559/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax RCPCh 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 _Chlamydophila felis_ (905 strain)
................................

10
3.0
EID
50
2
Attenuated feline panleucopenia virus (PLI IV)
...........................

10
3.5
CCID
50
1
Solvent:
ACTIVE SUBSTANCE:
FeLV recombinant canarypox virus (vCP97)
...............................

10
7.2
CCID
50
1
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 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 _Chlamydophila felis_ 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.
Onset of immunity: Rhinotracheitis, calicivirus,_ Chlamydophila felis_
and
panleucopenia components: 1 week after primary vaccination course.
Revised: March 2023
AN:
00559/2022
Page 2 of 6
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.
-
_Chlamydop
                                
                                Soma hati kamili