Purevax RCPCh FeLV | European Medicines Agency (2024)

Overview

Purevax RCPCh FeLV is a veterinary vaccine that is used to vaccinate cats from the age of 8 weeks against:

  • feline viral rhinotracheitis (a flu-like illness caused by a herpesvirus),
  • feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus),
  • feline chlamydiosis (a flu-like illness caused by the bacterium C. felis),
  • feline panleucopenia (a serious illness causing bloody diarrhoea caused by a parvovirus),
  • feline leukaemia (an illness affecting the immune system caused by a retrovirus, feline leukaemia virus).

The vaccine helps to reduce the symptoms of the diseases. It can also prevent death due to panleucopenia and prevent FeLV from remaining in the blood.

Purevax RCPCh FeLV contains:

  • attenuated (weakened) feline rhinotracheitis herpesvirus (FHV F2 strain),
  • inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains),
  • attenuated Chlamydophila felis (905 strain),
  • attenuated feline panleucopenia virus (PLI IV),
  • feline leukaemia virus (FeLV) recombinant canarypox virus (vCP97).

Purevax RCPCh FeLV is available as a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection. The vaccine is given as two doses injected under the skin. The first injection should be given in kittens aged at least eight weeks, with a second injection three to four weeks later. If the kitten has high levels of antibodies received from the mother in the womb and in the milk, the first vaccination should be delayed until 12 weeks of age. The cat should be revaccinated for all components one year after the first vaccination course, then every year for chlamydiosis and feline leukaemia, and every three years for rhinotracheitis, calicivirosis and panleucopenia.

For more information on how to use Purevax RCPCh FeLV, see the package leaflet or contact your veterinarian or pharmacist.

Purevax RCPCh FeLV is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Purevax RCPCh FeLV contains small amounts of weakened or killed viruses and bacteria that cause feline viral rhinotracheitis, calicivirosis, chlamydiosis and panleucopenia. To protect against feline leukaemia, the vaccine contains two genes from the FeLV called env and gag, which have been inserted into another vector (carrier) virus called canarypox using ‘recombinant DNA technology’. The canarypox viruses do not spread or multiply in the cat but they do produce proteins from the FeLV genes.

When a cat is given the vaccine, the immune system recognises the weakened or killed viruses, the FeLV proteins, and the weakened bacteria as ‘foreign’ and makes antibodies against them. In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses or bacteria. The antibodies will help to protect against the diseases caused by these viruses or bacteria. When exposed to any of these viruses or bacteria later in life, the cat will either not become infected or have a much less serious infection.

The effectiveness of Purevax RCPCh FeLV has been studied in several trials in laboratory conditions where cats were vaccinated and infected with herpesvirus, calicivirus, C. felis, parvovirus or leukaemia virus. In the field, the studies of Purevax RCPCh FeLV looked at the basic vaccination schedule (2 injections 3–4 weeks apart) and the booster vaccination. They included young and adult cats of various breeds, but not young kittens. The main measure of effectiveness was the level of antibodies in the blood against the viruses and bacteria in the vaccine, with the exception of the FeLV component, whose effectiveness in preventing infection had already been demonstrated in other studies.

In laboratory conditions, Purevax RCPCh FeLV was demonstrated to provide protection against the diseases listed above. In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus, calicivirus infection, and feline panleucopenia viruses. It was not possible to detect a rise in antibodies against C. felis because of high levels of antibodies in the cats at the beginning of the study. In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection, feline panleucopenia and C. felis remained stable at a high level or increased slightly.

The most common side effects with Purevax RCPCh FeLV (which may affect up to 1 in 10 animals) are temporary apathy (loss of interest in surroundings) and anorexia (loss of appetite), as well as hyperthermia (elevated body temperature) lasting for one or two days. There may be a local reaction at the injection site, with slight pain on touching, itching or oedema (swelling), which disappears within one or two weeks.

Purevax RCPCh FeLV should not be used in pregnant cats and during lactation.

For a full list of side effects and restrictions of Purevax RCPCh FeLV, see the package leaflet.

In case of accidental self-injection medical advice should be sought immediately and the package leaflet or the label shown to the doctor. The vaccine should not be handled by people with a weak immune system. If self-injection does occur in these people, the doctor should be told that self-injection with a live chlamydial vaccine has occurred.

The European Medicines Agency decided that Purevax RCPCh FeLV’s benefits are greater than its risks and it can be authorised for use in the EU.

Purevax RCPCh FeLV received a marketing authorisation valid throughout the EU on 23 February 2005.

Purevax RCPCh FeLV : EPAR - Medicine overview

Reference Number: EMA/499081/2006

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Product information

Purevax RCPCh FeLV : EPAR - Product Information

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Latest procedure affecting product information: WS2201/0034

17/02/2022

Purevax RCPCh FeLV : EPAR - All Authorised presentations

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Product details

Name of medicine

Purevax RCPCh FeLV

Active substance
  • 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)
  • attenuated Chlamydophila felis (905 strain)

International non-proprietary name (INN) or common name

vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia, feline leukeamia and feline Chlamydophila infections

Species

Cats

Anatomical therapeutic chemical veterinary (ATCvet) code

QI06AJ05

Pharmacotherapeutic group

Immunologicals for felidae

Therapeutic indication

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.

Onsets of immunity are 1 week after primary vaccination course for rhinotracheitis, calicivirus, Chlamydophila felis 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 chlamydiosis and feline leukaemia components, and one year after primary vaccination course and three years after the last re-vaccination for the rhinotracheitis, calicivirosis and panleucopenia components.

Authorisation details

EMA product number

EMEA/V/C/000085

Marketing authorisation holder

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein
Germany

Marketing authorisation issued

23/02/2005

Revision

15

Assessment history

Purevax RCPCh FeLV : EPAR - Procedural steps taken and scientific information after authorisation

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Purevax RCPCh FeLV : EPAR - Scientific Discussion

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News on Purevax RCPCh FeLV

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 May 2023

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 18-20 April 2023

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 December 2022

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 12-14 July 2022

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 February 2022

Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 18-19 January 2022

Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 5-7 October 2021

Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 13-15 April 2021

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 18-20 May 2020

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 22-24 January 2019

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17-19 April 2018

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 February 2018

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5–7 September 2017

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 June 2017

Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 8-10 November 2016

Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 6-8 October 2015

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 September 2015

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 7-9 July 2015

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 January 2015

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 9-11 December 2014

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 4-6 November 2014

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 9-11 September 2014

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 September 2012

Topics

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