NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax RCPCh FeLV lyophilisate and solvent for suspension for injection.
STATEMENT OF ACTIVE SUBSTANCES AND OTHER INGREDIENTS
For a dose of 1 ml or 0.5 ml:
Active substances:
Lyophilisate:
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ......................................... ³ 104.9 DICC501
Inactivated feline calicivirus antigens (FCV 431 and G1 strains) ......................... ³ 2.0 ELISA U
Attenuated Chlamydophila felis (strain 905) .............................................................................. ³ 103.0 DIE502
Attenuated feline panleukopenia virus (PLI IV) .............................................................. ³ 103.5 DICC501
Solvent:
FeLV canarypox virus recombinant (vCP97) .................................................................... ³ 107.2 DICC501
1 cell culture infectious dose 50%
2 embryo infectious dose 50%
Lyophilisate: homogeneous beige pellet.
Solvent: clear colorless liquid, shows suspended cell debris.
INDICATION(S)
Active immunization of cats 8 weeks of age and older:
against feline viral rhinotracheitis to reduce clinical signs,
against calicivirus infection to reduce clinical signs,
against Chlamydophila felis infections to reduce clinical signs,
against feline panleukopenia to prevent mortality and clinical signs,
against leukemia to prevent persistent viremia and clinical signs of the disease.
Onset of immunity: For rhinotracheitis, calicivirosis, Chlamydophila felis and panleukopenia: 1 week after the first vaccination.
For the feline leukaemia component: 2 weeks after the first vaccination.
Duration of immunity:
- For rhinotracheitis, calicivirosis and panleukopenia: 1 year after the first vaccination and 3 years after the last revaccination.
- For the Chlamydophila felis and feline leukaemia components: 1 year after the last revaccination.
CONTRAINDICATIONS
None.
ADVERSE EVENTS
Cats:
Common (1 to 10 animals/100 animals treated):
Temporary apathy, anorexia and hyperthermia1 (observed in safety and field studies).
Injection site reactions (mild tenderness, itching or limited oedema)2 (observed in safety and field studies).
Uncommon (1 to 10 animals/1000 animals treated):
Hypersensitivity reaction3 (seen in field studies)
Very rare (<1 animal/10,000 animals treated, including isolated reports):
Emesis4; transient hyperthermia and lethargy sometimes associated with lameness5 (in post-marketing safety monitoring)
1 usually lasting 1 to 2 days
2 resolved within 1 to 2 weeks at most
3 may require appropriate symptomatic treatment
4 mainly within 24 to 48 hours
5 seen 1 to 3 weeks after booster administration in adult cats
TARGET SPECIES Cats.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Subcutaneous use.
After reconstitution of the lyophilisate with 0.5 ml or 1 ml of solvent (depending on the chosen presentation), one dose of vaccine is injected according to the following vaccination schedule:
First vaccination:
First injection: starting at 8 weeks of age,
2nd injection: 3-4 weeks later.
In cases where a high level of maternal antibodies against components of rhinotracheitis, calicivirosis, panleukopenia or Chlamydophila is suspected (e.g. in kittens aged 9-12 weeks, born to cats that were vaccinated before gestation and/or exposed or suspected of previous exposure to the pathogen(s)), the first vaccination should be postponed until 12 weeks of age.
Revaccination:
The first revaccination should be carried out for all components one year after the first vaccination,
the following revaccinations:
- for the components against chlamydia and feline leukemia: every year.
- for the components against rhinotracheitis, calicivirosis and panleukopenia: at intervals of up to 3 years.
RECOMMENDATIONS ON CORRECT ADMINISTRATION
Carefully reconstitute the vaccine so as to obtain a uniform suspension with as little foam as possible. Visual appearance after reconstitution: yellowish suspension, showing suspended cell debris.
WITHDRAWAL TIME
Not applicable.
SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store and transport refrigerated (2 °C - 8 °C).
Protect from light.
Do not freeze.
Do not use this veterinary medicinal product after the expiry date which is stated on the bottle after EXP.
Shelf life after reconstitution according to directions: use immediately.
SPECIAL WARNINGS
Vaccination only healthy animals.
Special precautions for safe use in the target species:
It is recommended that a test for FeLV antigens be performed before vaccination.
Vaccination of FeLV positive cats does not provide any benefit.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of accidental self-injection with this product, seek medical advice immediately and show the package leaflet or the label to the physician. People with immunodeficiencies or those receiving immunosuppressive medicinal products should avoid contact with this product. In case of self-injection, seek medical advice immediately and inform the physician that the injection was made with a live chlamydial vaccine.
Pregnancy and lactation:
Do not use during the entire period of pregnancy and lactation.
Interaction with other veterinary medicinal products and other forms of interaction:
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day, but cannot be mixed with Boehringer Ingelheim adjuvanted rabies vaccine. No information is available on the safety and efficacy of the vaccine when used with other veterinary medicinal products, except those mentioned above. The decision to use this vaccine before or after other veterinary medicinal products should be made on a case-by-case basis.
Overdose:
No effects have been observed, except those mentioned in the section “Adverse events” and hyperthermia which may, in exceptional cases, last up to 5 days.
Major incompatibilities:
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with this veterinary medicinal product.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Ask your veterinarian how to dispose of medicines no longer required. These measures will help protect the environment.