Equilis Te

tetanus 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 Equilis Te?

Equilis Te is a vaccine for use in horses. It contains the toxoid (chemically inactivated toxin) from the tetanus bacterium.

It is available as a suspension for injection.

What is Equilis Te used for?

Equilis Te is used to vaccinate horses from six months of age against tetanus to prevent mortality. Tetanus is an acute, often fatal disease caused by a neurotoxin produced by the bacterium Clostridium tetani. The disease, which usually originates from contaminated wounds, is characterised by overall rigidity (stiffness) and convulsive spasms of the muscles. Horses belong to the most susceptible species to tetanus.

The vaccine is given as an injection into a muscle.

Horses should receive a primary vaccination, consisting of two injections given four weeks apart. To retain protection against tetanus, horses need to be revaccinated. The first revaccination should be no later than 17 months after primary vaccination. Afterwards, a maximum interval of two years is recommended.

How does Equilis Te work?

Equilis Te is a vaccine containing purified tetanus toxoid. The toxoid is a toxin processed in order to remove its toxic effect, but retain its antigenic properties.

Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against diseases. When the product is given to horses, it helps the animals’ immune system to react quicker when the animal is naturally exposed to the Clostridium tetani bacterium. This helps to protect against tetanus.

The vaccine also contains an ‘adjuvant’ to stimulate a better immune response.

How has Equilis Te been studied?

The safety of Equilis Te was studied in several studies under laboratory and field conditions in a large number of horses, from 2 months of age. All studies were performed with Equilis Prequenza Te (comment: double; mentioned in next paragraph).

It was concluded that the product is well tolerated by horses of different age. Studies in pregnant mares were also performed. No negative influence on gestation, foaling and offspring of mares was observed after vaccination at different times during pregnancy.

The effectiveness of Equilis Te has been studied in several trials under laboratory and field conditions. Most of the studies were performed with Equilis Prequenza Te, a vaccine that protects against equine influenza as well as against tetanus. For ethical reasons no challenge (infection) experiment was performed against tetanus. The main measure of effectiveness was the production of protective levels of antibodies against tetanus toxoid after vaccination.

What benefit has Equilis Te shown during the studies?

The studies showed that Equilis Te is an effective vaccine against tetanus to prevent mortality in horses from 6 months of age. Horses developed protection two weeks after primary vaccination. The duration of protection against tetanus was 17 months after primary vaccination and 24 months after the first revaccination.

What is the risk associated with Equilis Te?

Swelling (max. diameter 5 cm) may occur at the injection site, either as diffuse hard or soft swelling. The swelling is expected to decrease within two days. Pain at the injection site can occur occasionally. In some cases fever may occur for one day, and up to three days in exceptional circumstances.

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 doctor.

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 Equilis Te been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis Te exceeded the risks for the immunisation of horses from six months of age against tetanus to prevent mortality. The Committee recommended that Equilis Te should be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about Equilis Te

The European Commission granted a marketing authorisation valid throughout the European Union, for Equilis Te to Intervet International BV on 8 July 2005. Information on the prescription status of this product may be found on the label/outer package.

Name Language First published Last updated
Equilis Te : EPAR - Summary for the public BG = bălgarski 2009-01-15  
Equilis Te : EPAR - Summary for the public ES = español 2009-01-15  
Equilis Te : EPAR - Summary for the public CS = čeština 2009-01-15  
Equilis Te : EPAR - Summary for the public DA = dansk 2009-01-15  
Equilis Te : EPAR - Summary for the public DE = Deutsch 2009-01-15  
Equilis Te : EPAR - Summary for the public ET = eesti keel 2009-01-15  
Equilis Te : EPAR - Summary for the public EL = elliniká 2009-01-15  
Equilis Te : EPAR - Summary for the public EN = English 2009-01-15  
Equilis Te : EPAR - Summary for the public FR = français 2009-01-15  
Equilis Te : EPAR - Summary for the public IT = italiano 2009-01-15  
Equilis Te : EPAR - Summary for the public LV = latviešu valoda 2009-01-15  
Equilis Te : EPAR - Summary for the public LT = lietuvių kalba 2009-01-15  
Equilis Te : EPAR - Summary for the public HU = magyar 2009-01-15  
Equilis Te : EPAR - Summary for the public MT = Malti 2009-01-15  
Equilis Te : EPAR - Summary for the public NL = Nederlands 2009-01-15  
Equilis Te : EPAR - Summary for the public PL = polski 2009-01-15  
Equilis Te : EPAR - Summary for the public PT = português 2009-01-15  
Equilis Te : EPAR - Summary for the public RO = română 2009-01-15  
Equilis Te : EPAR - Summary for the public SK = slovenčina 2009-01-15  
Equilis Te : EPAR - Summary for the public SL = slovenščina 2009-01-15  
Equilis Te : EPAR - Summary for the public FI = suomi 2009-01-15  
Equilis Te : EPAR - Summary for the public SV = svenska 2009-01-15  

This EPAR was last updated on 30/09/2016 .

Authorisation details

Product details

Product details for Equilis Te
NameEquilis Te
Agency product numberEMEA/V/C/000093
Active substance

tetanus toxoid

International non-proprietary name (INN) or common name

Adjuvanted vaccine against tetanus

Species Horses
Anatomical therapeutic chemical veterinary (ATCvet) codeQI05AB03

Publication details

Publication details for Equilis Te
Marketing-authorisation holder

Intervet International BV

Revision6
Date of issue of marketing authorisation valid throughout the European Union08/07/2005

Contact address:

Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

Product information

20/09/2016  Equilis Te -EMEA/V/C/000093 -IA/007/G

Name Language First published Last updated
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30
Equilis Te : EPAR - Product Information SV = svenska 2008-07-24 2016-09-30

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
Equilis Te : EPAR - All Authorised presentations SV = svenska 2008-07-02  
Equilis Te : EPAR - All Authorised presentations SV = svenska 2008-07-02  
Equilis Te : EPAR - All Authorised presentations SV = svenska 2008-07-02  
Equilis Te : EPAR - All Authorised presentations SV = svenska 2008-07-02  
Equilis Te : EPAR - All Authorised presentations SV = svenska 2008-07-02  
Equilis Te : EPAR - All Authorised presentations SV = svenska 2008-07-02  
Equilis Te : EPAR - All Authorised presentations SV = svenska 2008-07-02  
Equilis Te : EPAR - All Authorised presentations SV = svenska 2008-07-02  
Equilis Te : EPAR - All Authorised presentations SV = svenska 2008-07-02  
Equilis Te : EPAR - All Authorised presentations SV = svenska 2008-07-02  
Equilis Te : EPAR - All Authorised presentations SV = svenska 2008-07-02  
Equilis Te : EPAR - All Authorised presentations SV = svenska 2008-07-02  
Equilis Te : EPAR - All Authorised presentations SV = svenska 2008-07-02  
Equilis Te : EPAR - All Authorised presentations SV = svenska 2008-07-02  
Equilis Te : EPAR - All Authorised presentations SV = svenska 2008-07-02  
Equilis Te : EPAR - All Authorised presentations SV = svenska 2008-07-02  
Equilis Te : EPAR - All Authorised presentations SV = svenska 2008-07-02  
Equilis Te : EPAR - All Authorised presentations SV = svenska 2008-07-02  
Equilis Te : EPAR - All Authorised presentations SV = svenska 2008-07-02  
Equilis Te : EPAR - All Authorised presentations SV = svenska 2008-07-02  
Equilis Te : EPAR - All Authorised presentations SV = svenska 2008-07-02  

Pharmacotherapeutic group

Immunologicals For equidae

Therapeutic indication

Active immunisation of horses from 6 months of age against tetanus to prevent mortality.

Onset of immunity: 2 weeks after the primary vaccination course

Duration of immunity: 17 months after the primary vaccination course, 24 months after the first revaccination

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Equilis Te : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2008-07-23 2016-09-30

Initial marketing-authorisation documents

Name Language First published Last updated
Equilis Te : EPAR - Scientific Discussion SV = svenska 2008-07-23  
Equilis Te : EPAR - Procedural steps taken before authorisation SV = svenska 2005-10-21