ProteqFlu

iInfluenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) and influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011)

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This is a summary of the European Public Assessment Report. 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 ProteqFlu?

ProteqFlu is a vaccine for use in horses. It contains parts of two equine influenza (flu) strains, which have been inserted into two canarypox vector (carrier) viruses respectively. ProteqFlu is available as a suspension for injection.

What is ProteqFlu used for?

ProteqFlu is used to vaccinate horses from 4 months of age against equine influenza. The vaccine reduces the clinical signs of equine influenza and the excretion (shedding) of the virus after infection. Equine influenza is a highly contagious disease that is very common in horses but rarely causes death.

The vaccine is given as an intramuscular injection (injection into a muscle). Horses should receive a primary vaccination, consisting of two injections at 5–6 months of age, given 4–6 weeks apart. This should be followed by revaccination 5 months later and afterwards by yearly booster vaccinations. In case of increased risk of infection or insufficient intake of colostrum (first milk), an additional initial injection can be given at the age of 4 months, followed by the full vaccination programme (primary vaccination and following revaccinations).

How does ProteqFlu work?

ProteqFlu is a vaccine which was produced with the use of recombinant DNA technology. This means that a gene from two different equine influenza strains (A/eq/Ohio/03 and A/eq/Richmond/1/07) was inserted into the canarypox vector viruses, which do not produce disease in horses, allowing the vector to produce specific proteins from these influenza strains.

Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against diseases. When ProteqFlu is given to horses, the animals’ immune system recognises the specific proteins from the equine influenza strains as ‘foreign’ and makes antibodies against them. The immune system will then be able to make those protective antibodies more quickly when the animal is naturally exposed to the equine flu viruses. This will help to protect against equine influenza.

ProteqFlu contains an adjuvant (carbomer) to enhance the immune response.

How has ProteqFlu been studied?

The effectiveness of ProteqFlu was first assessed in several laboratory and field studies. In laboratory studies, horses were challenged (infected) with equine influenza virus and the clinical signs and the excretion of the influenza virus after the challenge were compared between vaccinated and control animals (non-vaccinated animals or those vaccinated with a competitor product). The measure of effectiveness in all studies was antibody levels against the two influenza vaccine strains.

Most of the studies were performed with ProteqFlu-Te, a vaccine that protects against two strains of equine influenza as well as against tetanus.

The immunogenicity of the current formulation of the vaccine was confirmed in 15 foals.

What benefit has ProteqFlu-Te shown during the studies?

The studies showed that ProteqFlu was effective in reducing clinical signs and virus excretion after infection with equine influenza, 14 days after primary vaccination. The duration of protection was 5 months after primary vaccination and one year after the third vaccination.

The current formulation of ProteqFlu produced similar antibody responses against the two flu strains included in the vaccine to those seen in the main studies.

What is the risk associated with ProteqFlu?

A short lived swelling at the injection site may occur (max. diameter 5 cm) which decreases within 4 days.

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

In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.

What is the withdrawal period?

The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or milk used for human consumption. The withdrawal period for ProteqFlu for meat and milk is zero days.

Why has ProteqFlu been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ProteqFlu exceed the risks for the approved indication and recommended that ProteqFlu be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about ProteqFlu

The European Commission granted a marketing authorisation valid throughout the European Union for ProteqFlu on 6 March 2003. Information on the prescription status of this product may be found on the label/outer package.

Name Language First published Last updated
ProteqFlu : EPAR - Summary for the public BG = bălgarski 23/10/2008 17/10/2014
ProteqFlu : EPAR - Summary for the public ES = español 23/10/2008 17/10/2014
ProteqFlu : EPAR - Summary for the public CS = čeština 23/10/2008 17/10/2014
ProteqFlu : EPAR - Summary for the public DA = dansk 23/10/2008 17/10/2014
ProteqFlu : EPAR - Summary for the public DE = Deutsch 23/10/2008 17/10/2014
ProteqFlu : EPAR - Summary for the public ET = eesti keel 23/10/2008 17/10/2014
ProteqFlu : EPAR - Summary for the public EL = elliniká 23/10/2008 17/10/2014
ProteqFlu : EPAR - Summary for the public EN = English 23/10/2008 17/10/2014
ProteqFlu : EPAR - Summary for the public FR = français 23/10/2008 17/10/2014
ProteqFlu : EPAR - Summary for the public IT = italiano 23/10/2008 17/10/2014
ProteqFlu : EPAR - Summary for the public LV = latviešu valoda 23/10/2008 17/10/2014
ProteqFlu : EPAR - Summary for the public LT = lietuvių kalba 23/10/2008 17/10/2014
ProteqFlu : EPAR - Summary for the public HU = magyar 23/10/2008 17/10/2014
ProteqFlu : EPAR - Summary for the public MT = Malti 23/10/2008 17/10/2014
ProteqFlu : EPAR - Summary for the public NL = Nederlands 23/10/2008 17/10/2014
ProteqFlu : EPAR - Summary for the public PL = polski 23/10/2008 17/10/2014
ProteqFlu : EPAR - Summary for the public PT = português 23/10/2008 17/10/2014
ProteqFlu : EPAR - Summary for the public RO = română 23/10/2008 17/10/2014
ProteqFlu : EPAR - Summary for the public SK = slovenčina 23/10/2008 17/10/2014
ProteqFlu : EPAR - Summary for the public SL = slovenščina 23/10/2008 17/10/2014
ProteqFlu : EPAR - Summary for the public FI = suomi 23/10/2008 17/10/2014
ProteqFlu : EPAR - Summary for the public SV = svenska 23/10/2008 17/10/2014
ProteqFlu : EPAR - Summary for the public HR = Hrvatski 23/10/2008 17/10/2014

This EPAR was last updated on 17/10/2014 .

Authorisation details

Product details

Product details for ProteqFlu
NameProteqFlu
Agency product numberEMEA/V/C/000073
Active substance

iInfluenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) and influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011)

International non-proprietary name (INN) or common name

equine influenza vaccine

Species Horses
Anatomical therapeutic chemical veterinary (ATCvet) codeQI05AD02

Publication details

Publication details for ProteqFlu
Marketing-authorisation holder

Merial

Revision11
Date of issue of marketing authorisation valid throughout the European Union06/03/2003

Contact address:

Merial
29 avenue Tony Garnier
69007 Lyon
France

Product information

Product information

11/07/2014  ProteqFlu -EMEA/V/C/000073 -II/0014

Name Language First published Last updated
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - Product Information HR = Hrvatski 03/06/2008 17/10/2014

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
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2014

Pharmacotherapeutic group

Immunologicals, live viral vaccines for horses

Therapeutic indication

Active immunisation of horses of four months of age or older against equine influenza to reduce clinical signs and virus excretion after infection.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
ProteqFlu : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu-V-C-0073-II-14 : EPAR - Assessment Report - Variation HR = Hrvatski 17/10/2014  

Initial marketing-authorisation documents

Name Language First published Last updated
ProteqFlu : EPAR - Scientific Discussion HR = Hrvatski 03/06/2008  
ProteqFlu : EPAR - Procedural steps taken before authorisation HR = Hrvatski 10/08/2007