Purevax RCP FeLV
Active substance
ATC code
Species
Cats.
Indications
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.
Onset of immunity:
- Rhinotracheitis, calicivirus and panleucopenia component: 1 week after primary vaccination course.
- Feline Leukaemia component: 2 weeks after primary vaccination course.
Duration of immunity:
- Rhinotracheitis, calicivirus and panleucopenia component: 1 year after the primary vaccination course and 3 years after the last re-vaccination. - Feline leukaemia component: 1 year after the last re-vaccination.
Dose to be administered and administration route
Subcutaneous route.
Reconstitute gently the vaccine in order to obtain a uniform suspension with limited foam formation.
Visual appearance after reconstitution: clear slightly yellow suspension with presence of cell debris in suspension.
After reconstitution of the lyophilisate with 0.5 ml or 1 ml of the solvent
(depending on the presentation chosen), inject one dose of vaccine according to the following vaccination schedule:
Primary vaccination course:
- first injection: from 8 weeks of age, - second injection: 3 to 4 weeks later.
Where high levels of maternal antibodies against rhinotracheitis, calicivirosis or panleucopenia components are expected to be present (e.g. in kittens of 9 to 12 weeks of age born from queens which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Revaccination:
- the first revaccination must be carried out one year after the primary vaccination course,
Subsequent revaccinations:
- Feline leukaemia component: every year.
- Rhinotracheitis, calicivirosis and panleucopenia components: at intervals of up to three years.
Adverse reactions
Cats:
|
Common (1 to 10 animals / 100 animals treated): |
Apathy, anorexia, and hyperthermia1. Injection site reactions (pain, itching, oedema) 2. |
|
Uncommon (1 to 10 animals / 1 000 animals treated): |
Hypersensitivity reaction3. |
|
Very rare (<1 animal / 10 000 animals treated, including isolated reports): |
Emesis4. |
1 lasting usually for 1 or 2 days.
2 slight pain at palpation, itching or limited oedema disappearing within 1 or 2 weeks at most.
3 may require appropriate symptomatic treatment.
4 mostly within 24 to 48 hours.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder, or its local representative, or the national competent authority via the national reporting system. See section “Contact details” of the package leaflet.
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
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) ..... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and G1 strains) antigens . ≥ 2.0 ELISA U. Attenuated feline panleucopenia virus (PLI IV) ........................... ≥ 103.5 CCID501
Excipient:
Gentamicin, at most......................................................................23 µg
Solvent:
Active substance:
FeLV recombinant canarypox virus (vCP97) ............................... ≥ 10 7.2 CCID501
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.
4.3 Contraindications
None.
4.4 Special warnings for each target species
Vaccinate healthy animals only.
4.5 Special precautions for use
Special precautions for use in animals
It is recommended that a test for FeLV antigenaemia be carried out prior to vaccination. Vaccination of FeLV positive cats is of no benefit.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
4.6 Adverse reactions (frequency and seriousness)
Transient apathy and anorexia as well as hyperthermia (lasting usually for 1 or 2 days) were commonly observed during safety and field studies. A local reaction (slight pain at palpation, itching or limited oedema) that disappears within 1 or 2 weeks at most was commonly observed during safety and field studies.
Emesis (mostly within 24 to 48 hours) has been observed in very rare cases based on post-marketing safety experience.
A hypersensitivity reaction has been observed uncommonly in field studies, which may require appropriate symptomatic treatment.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals treated in 100 animals)
- uncommon (more than 1 but less than 10 animals treated in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
4.7 Use during pregnancy, lactation or lay
Do not use during the whole pregnancy and lactation.
4.8 Interaction with other medicinal products and other forms of interaction
Safety and efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with Boehringer Ingelheim adjuvanted vaccine against rabies.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
4.9 Amounts to be administered and administration route
Subcutaneous route.
Reconstitute gently the vaccine in order to obtain a uniform suspension with limited foam formation.
Visual appearance after reconstitution: slightly yellow suspension with presence of cell debris in suspension.
After reconstitution of the lyophilisate with 0.5 ml or 1 ml of the solvent (depending on the presentation chosen) inject one dose of vaccine according to the following vaccination scheme:
Primary vaccination course:
- first injection: from 8 weeks of age, - second injection: 3 to 4 weeks later.
Where high levels of maternal antibodies against rhinotracheitis, calicivirosis or panleucopenia components are expected to be present (e.g. in kittens of 9 to 12 weeks of age born from queens, which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Revaccination:
- the first revaccination must be carried out for all components one year after the primary vaccination course,
- Subsequent revaccinations:
- Feline leukaemia component: every year.
- Rhinotracheitis, calicivirosis and panleucopenia components: at intervals of up to three years.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No effect other than those already mentioned in section 4.6 “Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days.
4.11 Withdrawal period(s)
Not applicable.
5. IMMUNOLOGICAL PROPERTIES
ATCvet code: QI06AH10. live feline rhinotracheitis virus + live feline panleucopenia virus / parvovirus + inactivated feline calicivirus + feline leukaemia, recombinant live canarypox virus
Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline leukaemia.
Stimulates active immunity against feline rhinotracheitis virus, feline calicivirus, feline panleucopenia virus and feline leukaemia virus.
The product was shown to reduce excretion of feline calicivirus at onset of immunity and for one year after vaccination.
The feline leukaemia vaccine strain is a recombinant canarypox virus expressing the env and gag genes of FeLV-A. Under field conditions, only sub-group A is infective and immunisation against sub-group A provides full protection against A, B and C. After inoculation, the virus expresses the protective proteins, but does not replicate in the cat. As a consequence, the vaccine induces an immune status against feline leukaemia virus.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose
Sorbitol
Dextran 40
Casein hydrolysate
Collagen hydrolysate
Dipotassium phosphate
Potassium dihydrogen phosphate
Potassium hydroxide
Sodium chloride
Potassium chloride
Disodium phosphate dihydrate
Magnesium chloride hexahydrate
Calcium chloride dihydrate Water for injections
6.2 Major incompatibilities
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the product.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
Shelf life after reconstitution according to directions: use immediately.
6.4 Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Protect from light. Do not freeze.
6.5 Nature and composition of immediate packaging
Type I glass bottle containing 1 dose of lyophilisate and type I glass bottle containing 0.5 ml or 1 ml solvent, both closed with a butyl elastomer closure and sealed with an aluminium cap.
Plastic box containing 10 bottles of 1 dose of lyophilisate and 10 bottles of 1 ml of solvent.
Plastic box containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 1 ml of solvent.
Plastic box containing 10 bottles of 1 dose of lyophilisate and 10 bottles of 0.5 ml of solvent.
Plastic box containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 0.5 ml of solvent.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim Vetmedica GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
8. MARKETING AUTHORISATION NUMBER
Vm 04491/5054
9. DATE OF FIRST AUTHORISATION
23 February 2005
10. DATE OF REVISION OF THE TEXT
March 2023
Approved: 09 March 2023
| Art. Nr. | 04491/5054 |
|---|---|
| EAN | 4028691577942 |
