Bovalto Ibraxion

inactivated IBR virus

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This is a summary of the European public assessment report (EPAR) for Bovalto Ibraxion.It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Bovalto Ibraxion.

For practical information about using Bovalto Ibraxion, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

What is Bovalto Ibraxion and what is it used for?

Bovalto Ibraxion is a veterinary vaccine used to protect cattle against infectious bovine rhinotracheitis (IBR) virus. IBR virus infections affect the airways with nasal discharge, conjunctivitis (inflammation of the eye) and coughing.

Bovalto Ibraxion contains the active substance inactivated gene deleted IBR virus.

How is Bovalto Ibraxion used?

Bovalto Ibraxion is available as an emulsion and can only be obtained with a prescription. The vaccine is given into the neck at the front of the shoulder. Two injections are given 3 weeks apart to calves from age 2 weeks provided they have not acquired antibodies against IBR virus from the mother. When there are antibodies the vaccine should be given to calves from age 3 months. A booster injection is given at 6 month intervals.

Protection starts 2 weeks after vaccination and lasts for 6 months.

For further information, see the package leaflet.

How does Bovalto Ibraxion work?

Bovalto Ibraxion is a vaccine containing a version of the IBR virus that has been made inactive so it cannot cause infection. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. When Bovalto Ibraxion is given to cattle the animals’ immune system recognises the inactive virus as ‘foreign’ and makes antibodies against it.

In the future, if the animals are exposed to the active virus the immune system will be able to respond more quickly. The virus in the vaccine has also been modified to allow vaccinated animals to be distinguished from naturally infected animals so allowing better disease management.

Bovalto Ibraxion contains the adjuvant light paraffin oil to enhance the immune response.

What benefits of Bovalto Ibraxion have been shown in studies?

Field studies were conducted in around 300 cattle of various ages in both an IBR contaminated and an IBR free environment. Cattle vaccinated with Bovalto Ibraxion had protective levels of antibodies to IBR virus at 2 weeks after vaccination and the duration of protection was shown to last 6 months.

What are the risks associated with Bovalto Ibraxion?

The injection of Bovalto 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.

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

Bovalto Ibraxion is an emulsion containing mineral oil. Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger –this could result in the loss of a finger if prompt medical attention is not given. If someone is accidentally injected with this product, they must seek medical attention immediately even if only a very small amount is injected. The package leaflet should be shown to the doctor. If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.

What is the withdrawal period in food-producing animals?

The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption. It is also the time required after administration of a medicine before milk may be used for human consumption.

The withdrawal period for meat and milk from cattle treated with Bovalto Ibraxion is ‘zero’ days, which means there is no mandatory waiting time.

Why is Bovalto Ibraxion approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Bovalto Ibraxion’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Bovalto Ibraxion

The European Commission granted a marketing authorisation valid throughout the EU for Bovalto Ibraxion on 9 March 2000.

The name of the medicine was changed to Bovalto Ibraxion on 10 August 2016.

For more information about treatment with Bovalto Ibraxion, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Name Language First published Last updated
Ibraxion : EPAR - Summary for the public BG = bălgarski 2007-05-02 2016-12-21
Ibraxion : EPAR - Summary for the public ES = español 2007-05-02 2016-12-21
Ibraxion : EPAR - Summary for the public CS = čeština 2007-05-02 2016-12-21
Ibraxion : EPAR - Summary for the public DA = dansk 2007-05-02 2016-12-21
Ibraxion : EPAR - Summary for the public DE = Deutsch 2007-05-02 2016-12-21
Ibraxion : EPAR - Summary for the public ET = eesti keel 2007-05-02 2016-12-21
Ibraxion : EPAR - Summary for the public EL = elliniká 2007-05-02 2016-12-21
Ibraxion : EPAR - Summary for the public EN = English 2007-05-02 2016-12-21
Ibraxion : EPAR - Summary for the public FR = français 2007-05-02 2016-12-21
Ibraxion : EPAR - Summary for the public IT = italiano 2007-05-02 2016-12-21
Ibraxion : EPAR - Summary for the public LV = latviešu valoda 2007-05-02 2016-12-21
Ibraxion : EPAR - Summary for the public LT = lietuvių kalba 2007-05-02 2016-12-21
Ibraxion : EPAR - Summary for the public HU = magyar 2007-05-02 2016-12-21
Ibraxion : EPAR - Summary for the public MT = Malti 2007-05-02 2016-12-21
Ibraxion : EPAR - Summary for the public NL = Nederlands 2007-05-02 2016-12-21
Ibraxion : EPAR - Summary for the public PL = polski 2007-05-02 2016-12-21
Ibraxion : EPAR - Summary for the public PT = português 2007-05-02 2016-12-21
Ibraxion : EPAR - Summary for the public RO = română 2007-05-02 2016-12-21
Ibraxion : EPAR - Summary for the public SK = slovenčina 2007-05-02 2016-12-21
Ibraxion : EPAR - Summary for the public SL = slovenščina 2007-05-02 2016-12-21
Ibraxion : EPAR - Summary for the public FI = suomi 2007-05-02 2016-12-21
Ibraxion : EPAR - Summary for the public SV = svenska 2007-05-02 2016-12-21
Ibraxion : EPAR - Summary for the public HR = Hrvatski 2007-05-02 2016-12-21

This EPAR was last updated on 21/12/2016 .

Authorisation details

Product details

Product details for Bovalto Ibraxion
NameBovalto Ibraxion
Agency product numberEMEA/V/C/000051
Active substance

inactivated IBR virus

International non-proprietary name (INN) or common name

Infectious bovine rhinotracheitis vaccine (inactivated)

Species Cattle
Anatomical therapeutic chemical veterinary (ATCvet) codes QI02AA03







Publication details

Publication details for Bovalto Ibraxion
Marketing-authorisation holder

Merial

Revision10
Date of issue of marketing authorisation valid throughout the European Union09/03/2000

Contact address:

Merial
29 avenue Tony Garnier
69007 Lyon
France

Product information

Product information

10/08/2016  Bovalto Ibraxion -EMEA/V/C/000051 -IAIN/0016

Name Language First published Last updated
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12
Ibraxion : EPAR - Product Information HR = Hrvatski 2008-04-04 2016-08-12

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
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12
Ibraxion : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2016-08-12

Pharmacotherapeutic group

Immunologicals for bovidae

Therapeutic indication

Active immunisation of cattle to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus excretion.
The onset of immunity is 14 days and the duration of immunity is 6 months.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Ibraxion : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2008-04-04 2016-08-12

Initial marketing-authorisation documents

Name Language First published Last updated
Ibraxion : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2006-08-07  
Ibraxion : EPAR - Scientific Discussion HR = Hrvatski 2006-08-07