Equilis Te
European Medicines Agency Veterinary Medicines
EMEA/V/C/093
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) EQUILIS TE
EPAR summary for the public
This document 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 document 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.
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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.
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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.
This summary was last updated in October 2008.
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©EMEA 2008