ProteqFlu-Te

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

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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 ProteqFlu-Te?

ProteqFlu-Te is a vaccine for use in horses. It contains parts of two equine influenza (flu) strains, which have been inserted into two canarypox vector viruses respectively, and a tetanus toxoid (chemically weakened toxins from the tetanus bacterium). ProteqFlu-Te is available as a suspension for injection.

What is ProteqFlu-Te used for?

ProteqFlu-Te is used to vaccinate horses from four months of age against equine influenza and tetanus. 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 also stimulates protection against tetanus to prevent mortality. Tetanus is an acute, often fatal disease caused by the neurotoxin of the bacterium Clostridium tetani. The disease, which usually originates from contaminated wounds, is characterised by overall rigidity (stiffness) and convulsive spasms of the muscles. The muscle stiffness usually starts from the jaw and neck, then affects the whole body. Horses are among the most susceptible species to tetanus.

The vaccine is given as an intramuscular injection (injection into a muscle). Horses should receive a primary vaccination, consisting of two injections at five to six months of age, given four to six weeks apart. This should be followed by revaccination five 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 four months, followed by the full vaccination programme (primary vaccination and following revaccinations).

How does ProteqFlu-Te work?

ProteqFlu-Te is a vaccine which was produced with the use of recombinant technology. This means that a gene from two different equine influenza strains (A/equi-2/Ohio/03 and A/equi-2/Newmarket/2/93) was inserted into two live canarypox vector viruses respectively, which made them capable of producing parts of these influenza strains (specific proteins). The vaccine also contains a tetanus toxoid, which is a tetanus toxin processed in order to decrease its toxic effect but retain its antigenic power.

Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against diseases. When ProteqFlu-Te is given to a horse, the animal's immune system recognises the specific proteins from the equine influenza strains and the tetanus toxoid 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 and the tetanus bacterium. This will help to protect against equine influenza and tetanus. The vaccine also contains an ‘adjuvant’ to stimulate a better response.

How has ProteqFlu-Te been studied?

The safety of ProteqFlu-Te was studied in several studies under laboratory and field conditions in a large number of horses, of all ages (from 1 month to 40 years) and physiological status (foals, non-pregnant and pregnant female adults and male adults). It was concluded that the product is safe at very high doses in the target species, also in pregnant mares, whatever the stage of pregnancy. It was also shown that, when used in the horse, the live viruses contained in the vaccine do not spread, disseminate or replicate at the site of inoculation and do not recombine with other viruses. No environmental risks were identified through the use of this vaccine.

The effectiveness of ProteqFlu-Te was studied in several studies under laboratory and field conditions. In studies under laboratory conditions, horses were challenged (infected) with equine influenza virus. The clinical signs and the excretion of the influenza virus after the challenge were compared between vaccinated and control animals (unvaccinated animals or animals vaccinated with a competitive product). The production of protective levels of antibodies against the two influenza vaccine strains was measured in all studies. Regarding tetanus, no challenge (infection) experiment was performed for ethical reasons. The measure of effectiveness was the production of protective levels of antibodies against tetanus toxoid after vaccination.

What benefit has ProteqFlu-Te shown during the studies?

The studies showed that ProteqFlu-Te is an effective vaccine in horses from four months of age or older against equine influenza to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality from 14 days after primary vaccination. The duration of protection was five months after primary vaccination and one year after the third vaccination.

What is the risk associated with ProteqFlu-Te?

Swelling may occur (maximum diameter 5 cm), which decreases within four days. Pain and local hyperthermia (increase in body temperature) can occur in rare cases. A slight increase in temperature (maximum 1.5°C) may occur for one day, exceptionally for two days.

In exceptional circumstances, apathy and reduced appetite may be observed the day after vaccination. Also in exceptional circumstances, a hypersensitivity (allergic) reaction can occur, which may require appropriate symptomatic treatment.

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

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?

The withdrawal period of the product is zero days.

What is the time to allow before milk can be taken from the animal for human consumption?

Zero days.

Why has ProteqFlu-Te been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ProteqFlu-Te exceed the risks for the active immunisation of horses of four months of age or older against equine influenza to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality. The Committee recommended that ProteqFlu-Te be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about ProteqFlu-Te

The European Commission granted a marketing authorisation valid throughout the European Union, for ProteqFlu-Te to Merial S.A.S. 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-Te : EPAR - Summary for the public BG = bălgarski 23/10/2008 13/11/2014
ProteqFlu-Te : EPAR - Summary for the public ES = español 23/10/2008 13/11/2014
ProteqFlu-Te : EPAR - Summary for the public CS = čeština 23/10/2008 13/11/2014
ProteqFlu-Te : EPAR - Summary for the public DA = dansk 23/10/2008 13/11/2014
ProteqFlu-Te : EPAR - Summary for the public DE = Deutsch 23/10/2008 13/11/2014
ProteqFlu-Te : EPAR - Summary for the public ET = eesti keel 23/10/2008 13/11/2014
ProteqFlu-Te : EPAR - Summary for the public EL = elliniká 23/10/2008 13/11/2014
ProteqFlu-Te : EPAR - Summary for the public EN = English 23/10/2008 13/11/2014
ProteqFlu-Te : EPAR - Summary for the public FR = français 23/10/2008 13/11/2014
ProteqFlu-Te : EPAR - Summary for the public IT = italiano 23/10/2008 13/11/2014
ProteqFlu-Te : EPAR - Summary for the public LV = latviešu valoda 23/10/2008 13/11/2014
ProteqFlu-Te : EPAR - Summary for the public LT = lietuvių kalba 23/10/2008 13/11/2014
ProteqFlu-Te : EPAR - Summary for the public HU = magyar 23/10/2008 13/11/2014
ProteqFlu-Te : EPAR - Summary for the public MT = Malti 23/10/2008 13/11/2014
ProteqFlu-Te : EPAR - Summary for the public NL = Nederlands 23/10/2008 13/11/2014
ProteqFlu-Te : EPAR - Summary for the public PL = polski 23/10/2008 13/11/2014
ProteqFlu-Te : EPAR - Summary for the public PT = português 23/10/2008 13/11/2014
ProteqFlu-Te : EPAR - Summary for the public RO = română 23/10/2008 13/11/2014
ProteqFlu-Te : EPAR - Summary for the public SK = slovenčina 23/10/2008 13/11/2014
ProteqFlu-Te : EPAR - Summary for the public SL = slovenščina 23/10/2008 13/11/2014
ProteqFlu-Te : EPAR - Summary for the public FI = suomi 23/10/2008 13/11/2014
ProteqFlu-Te : EPAR - Summary for the public SV = svenska 23/10/2008 13/11/2014
ProteqFlu-Te : EPAR - Summary for the public HR = Hrvatski 23/10/2008 13/11/2014

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

Authorisation details

Product details

Product details for ProteqFlu-Te
NameProteqFlu-Te
Agency product numberEMEA/V/C/000074
Active substance

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

International non-proprietary name (INN) or common name

equine influenza and tetanus vaccine

Species Horses
Anatomical therapeutic chemical veterinary (ATCvet) codeQI05AI01

Publication details

Publication details for ProteqFlu-Te
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-Te -EMEA/V/C/000074 -II/0017

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

Pharmacotherapeutic group

Immunologicals for equidae

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, and against tetanus to prevent mortality.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
ProteqFlu-Te : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 03/06/2008 17/10/2014
ProteqFlu-Te-V-C-0074-II-17 : EPAR - Assessment Report - Variation HR = Hrvatski 17/10/2014  

Initial marketing-authorisation documents

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