Ibraxion
European Medicines Agency
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) IBRAXION
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 Ibraxion?
Ibraxion is an emulsion for injection. Each 2 ml dose of Ibraxion contains the active substance inactivated gene deleted Infectious Bovine Rhinotracheitis (IBR) virus. This deletion allows to differentiate vaccinated animals from infected animals allowing a better management of the disease.
What is Ibraxion used for?
Ibraxion is used to immunise cattle to reduce the clinical signs of IBR and reduce field virus excretion (virus that is passed out of the animal).
Ibraxion is shaken before use and injected subcutaneously (under the skin) into the neck at the front of the shoulder. Two injections are given 21 days apart in animals from the age of 2 weeks where there are no antibodies against IBR virus from the mother. If there are antibodies, the vaccine should be given from the age of 3 months. To revaccinate, a booster injection should be given at 6-month intervals. Immunity starts after 14 days and lasts for 6 months.
How does Ibraxion work?
Ibraxion contains a gene deleted IBR virus, which is inactivated. When injected, this exposure helps the calf s immune system to recognise and fight the IBR virus. When exposed to IBR virus later in life, the calf will either not become infected or have a much less serious infection. Ibraxion is also intended to reduce the spread of the IBR virus by reducing the amount of virus excreted by the animals.
How has the effectiveness of Ibraxion been studied?
Ibraxion has been studied using the recommended dosing in all categories and age groups of animals. The effect of antibodies passed on by the mother was also investigated. The protection given by Ibraxion was measured by the reduction of clinical signs of IBR after the virus was introduced to the cattle.
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What benefit has Ibraxion shown during the studies?
The results of the trials showed that vaccination by Ibraxion of calves either not less than 3 to 4 months of age (if they have antibodies to IBR that have been passed on from their mother) or from 2-week of age (if they have no maternal antibodies). provided protection from IBR for six months. The studies also confirmed the effect of a booster injection at 15 months after the first vaccination (the booster for Ibrax is recommended every 6 months). Finally, it was shown that vaccination with Ibraxion did not induced antibodies against gE, allowing differentation between those animals and IBR infected ones.
What are the side effects of Ibraxion?
The injection of Ibraxion may cause a temporary tissue reaction at the site of injection, which may last for three weeks and rarely up to five weeks. Ibraxion may cause a slight rise in body temperature (less than 1°C) for less than 48 hours after injection. This does not affect the health or performance of the animal. Rarely, a hypersensitivity (allergic) reaction may occur, which requires treatment.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
Ibraxion 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 Ibraxion been approved?
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Ibraxion are greater than any risks to immunise cattle to reduce the clinical signs of IBR and reduce field virus excretion. They recommended that Ibraxion should be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.
Other information about Ibraxion:
The European Commission granted a marketing authorisation valid throughout the European Union, for Ibraxion to Merial on 9 March 2000. Information on the prescription status of this product may be found on the labelling.
This summary was last updated in 11-2006.
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