Purevax RCP FeLV Lyophilisate and Solvent for Suspension for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

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

Available from:

Boehringer Ingelheim Vetmedica Gmbh

ATC code:

QI06AH10

INN (International Name):

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

Pharmaceutical form:

Powder and solvent for suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats

Therapeutic area:

Live and Inactivated Viral Vaccine

Authorization status:

Authorized

Authorization date:

2005-02-23

Summary of Product characteristics

Revised: March 2023
AN: 01446/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
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.
Revised: March 2023
AN: 01446/2022
Page 2 of 6
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.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNING