Fevaxyn Pentofel

inactivated feline calicivirus / inactivated feline Chlamydophila felis / inactivated feline leukaemia virus / inactivated feline panleukopenia virus / inactivated feline rhinotracheitis virus

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This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

What is Fevaxyn Pentofel?

Fevaxyn Pentofel is a vaccine for cats, which is a solution for injection in a prefilled syringe. Fevaxyn Pentofel contains the following inactivated viruses: feline panleukopenia virus, feline rhinotracheitis virus, feline calicivirus, feline leukaemia virus, and the inactivated bacterium feline Chlamydophila felis.

What is Fevaxyn Pentofel used for?

Fevaxyn Pentofel is used to immunise healthy cats of nine weeks or older against feline panleukopenia and feline leukaemia, and against respiratory diseases caused by feline rhinotracheitis virus, feline calicivirus and feline Chlamydophila felis.

The contents of the prefilled syringe are shaken and given by subcutaneous (under the skin) injection. For cats nine weeks and older, two doses are given at an interval of three to four weeks. An additional dose is recommended for kittens living in high-risk areas for feline leukaemia virus whose first dose was administered before 12 weeks of age. Fevaxyn Pentofel is then given once every year.

How does Fevaxyn Pentofel work?

Fevaxyn Pentofel contains small amounts of four inactivated viruses and one inactivated bacterium. When injected, this small exposure helps the cat’s immune system to recognise and attack the viruses and bacterium. When exposed to any of these viruses and bacterium later in life, the cat will either not become infected or will have a much less serious infection.

How has the effectiveness of Fevaxyn Pentofel been studied?

Fevaxyn Pentofel has been studied against feline leukaemia, against respiratory diseases caused by feline rhinotracheitis virus, feline calicivirus and feline Chlamydophila felis, and against disease caused by feline panleukopenia virus.

In addition, studies in cats of various breeds were carried out to observe any side effects of Fevaxyn Pentofel after the first and second vaccinations.

What benefit has Fevaxyn Pentofel shown during the studies?

Fevaxyn Pentofel has been shown to be effective against feline leukaemia, against respiratory diseases caused by feline rhinotracheitis virus, feline calicivirus and feline Chlamydophila felis, and against disease caused by feline panleukopenia virus.

In the trial to observe side effects, there were no side effects in 94.2% of cats for the first vaccination and no side effects observed for 99% of cats for the second vaccination.

What are the side effects of Fevaxyn Pentofel?

Some vaccinated cats may develop reactions to the vaccine, which include temporary fever, vomiting, anorexia (not eating) or depression, which usually disappear within 24 hours.

Occasionally there is swelling, pain, pruritus (itching) or hair loss at the injection site. In very rare cases, there is an anaphylactic reaction (severe allergy) with oedema (fluid under the skin), pruritus, respiratory and cardiac distress, severe gastrointestinal signs or shock during the first hours after vaccination.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

Fevaxyn Pentofel contains mineral oil. Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger, rarely causing the loss of a finger. If someone is accidentally injected with this product, they must seek immediate medical advice even if only a very small amount is injected. The package leaflet should be taken to the doctor. If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.

Why has Fevaxyn Pentofel been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Fevaxyn Pentofel are greater than any risks to immunise healthy cats of nine weeks or older against feline viruses. It recommended that Fevaxyn Pentofel should be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion of this EPAR.

Other information about Fevaxyn Pentofel

The European Commission granted a marketing authorisation valid throughout the European Union for Fevaxyn Pentofel on 5 February 1997. Information on the prescription status of this product may be found on the outer package.

Name Language First published Last updated
Fevaxyn Pentofel : EPAR - Summary for the public BG = bălgarski 2007-03-08 2013-06-07
Fevaxyn Pentofel : EPAR - Summary for the public ES = español 2007-03-08 2013-06-07
Fevaxyn Pentofel : EPAR - Summary for the public CS = čeština 2007-03-08 2013-06-07
Fevaxyn Pentofel : EPAR - Summary for the public DA = dansk 2007-03-08 2013-06-07
Fevaxyn Pentofel : EPAR - Summary for the public DE = Deutsch 2007-03-08 2013-06-07
Fevaxyn Pentofel : EPAR - Summary for the public ET = eesti keel 2007-03-08 2013-06-07
Fevaxyn Pentofel : EPAR - Summary for the public EL = elliniká 2007-03-08 2013-06-07
Fevaxyn Pentofel : EPAR - Summary for the public EN = English 2007-03-08 2013-06-07
Fevaxyn Pentofel : EPAR - Summary for the public FR = français 2007-03-08 2013-06-07
Fevaxyn Pentofel : EPAR - Summary for the public IT = italiano 2007-03-08 2013-06-07
Fevaxyn Pentofel : EPAR - Summary for the public LV = latviešu valoda 2007-03-08 2013-06-07
Fevaxyn Pentofel : EPAR - Summary for the public LT = lietuvių kalba 2007-03-08 2013-06-07
Fevaxyn Pentofel : EPAR - Summary for the public HU = magyar 2007-03-08 2013-06-07
Fevaxyn Pentofel : EPAR - Summary for the public MT = Malti 2007-03-08 2013-06-07
Fevaxyn Pentofel : EPAR - Summary for the public NL = Nederlands 2007-03-08 2013-06-07
Fevaxyn Pentofel : EPAR - Summary for the public PL = polski 2007-03-08 2013-06-07
Fevaxyn Pentofel : EPAR - Summary for the public PT = português 2007-03-08 2013-06-07
Fevaxyn Pentofel : EPAR - Summary for the public RO = română 2007-03-08 2013-06-07
Fevaxyn Pentofel : EPAR - Summary for the public SK = slovenčina 2007-03-08 2013-06-07
Fevaxyn Pentofel : EPAR - Summary for the public SL = slovenščina 2007-03-08 2013-06-07
Fevaxyn Pentofel : EPAR - Summary for the public FI = suomi 2007-03-08 2013-06-07
Fevaxyn Pentofel : EPAR - Summary for the public SV = svenska 2007-03-08 2013-06-07

This EPAR was last updated on 10/04/2017 .

Authorisation details

Product details

Product details for Fevaxyn Pentofel
NameFevaxyn Pentofel
Agency product numberEMEA/V/C/000030
Active substance

inactivated feline calicivirus / inactivated feline Chlamydophila felis / inactivated feline leukaemia virus / inactivated feline panleukopenia virus / inactivated feline rhinotracheitis virus

International non-proprietary name (INN) or common name

inactivated feline panleukopenia virus, calicivirus, rhinotracheitis virus, leukaemia virus and Chlamydophila felis

Species Cats
Anatomical therapeutic chemical veterinary (ATCvet) codes QI06AL01







Publication details

Publication details for Fevaxyn Pentofel
Marketing-authorisation holder

Zoetis Belgium SA
 

Revision18
Date of issue of marketing authorisation valid throughout the European Union05/02/1997

Contact address:

Zoetis Belgium SA
Rue Laid Burnait, 1
1348 Louvain-la-Neuve
Belgium

Product information

Product information

23/03/2017  Fevaxyn Pentofel -EMEA/V/C/000030 -IG/0747

Name Language First published Last updated
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10
Fevaxyn Pentofel : EPAR - Product Information SV = svenska 2009-10-15 2017-04-10

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28
Fevaxyn Pentofel : EPAR - All Authorised presentations SV = svenska 2009-01-26 2015-04-28

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

For the active immunisation of healthy cats nine weeks or older against feline panleukopenia and feline leukaemia viruses and against respiratory diseases caused by feline rhinotracheitis virus, feline calicivirus and Chlamydophila felis.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Fevaxyn Pentofel : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2009-10-15 2017-04-10

Initial marketing-authorisation documents

Name Language First published Last updated
Fevaxyn Pentofel : EPAR - Procedural steps taken before authorisation SV = svenska 2007-03-08  
Fevaxyn Pentofel : EPAR - Scientific Discussion SV = svenska 2007-03-08