Bluevac BTV8

bluetongue virus inactivated, serotype 8

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About

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 Bluevac BTV8 and what is it used for?

Bluevac BTV8 is a vaccine used in cattle and sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus, which is transmitted by midges. Clinical signs of the disease include fever, skin ulceration, as well as swelling and occasionally blueish discolouration of the tongue mainly seen in sheep. The vaccine is used to prevent viraemia (the presence of viruses in the blood) and to reduce clinical signs caused by bluetongue virus in sheep and to prevent viraemia in cattle. The vaccine contains inactivated (killed) bluetongue virus serotype 8.

How is Bluevac BTV8 used?

The vaccine is available as a suspension for injection and can only be obtained with a prescription.

The vaccine is given to cattle and sheep as two injections under the skin. The first injection is given from two and a half months of age and a second injection is given three weeks later. For booster vaccination a single injection is given every year. Protection starts 31 days after the second injection in cattle and 20 days after the second injection in sheep. Protection lasts for one year.

How does Bluevac BTV8 work?

Bluevac BTV8 is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Bluevac BTV8 contains a bluetongue virus that has been inactivated so that it cannot cause the disease. When it is given to cattle and sheep, the animals’ immune system recognises the virus as ‘foreign’ and produces antibodies against it. In the future, if the animals are exposed to the same type of bluetongue virus, the immune system will be able to produce antibodies more quickly. This will help to protect against the disease.

Bluevac BTV8 contains bluetongue viruses of one type (‘serotype 8’). The vaccine also contains ‘adjuvants’ (aluminium hydroxide and saponin) to stimulate a better reaction by the immune system.

What benefits have Bluevac BTV8 shown in studies?

The effectiveness of the vaccine was investigated in a number of laboratory trials in sheep and cattle of the minimum recommended age. The main measures of the effectiveness of the vaccine were viraemia (levels of BTV8 in the blood) and clinical signs of bluetongue virus infection. In all studies the vaccinated sheep and cattle were compared with unvaccinated animals (controls). The studies showed that the vaccine prevents viraemia in sheep and cattle and reduces clinical signs in sheep when infected with bluetongue virus serotype 8.

What are the risks associated with Bluevac BTV8?

The most common side effect with Bluevac BTV8 (which may affect up to 1 in 10 animals) is an increase in body temperature between 0.5 and 1.0˚C that lasts no longer than one to two days.

For the full list of restrictions and all side effects reported with Bluevac BTV8, see the package leaflet.

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

No special precautions are required.

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 and sheep treated with Bluevac BTV8 is ‘zero’ days, which means that there is no mandatory waiting time.

Why is Bluevac BTV8 approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Bluevac BTV8’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Bluevac BTV8 was originally authorised under ‘exceptional circumstances’ because, as bluetongue disease falls under national disease control programmes, limited information was available at the time of approval. As the company had supplied the additional information requested, the ‘exceptional circumstances’ ended on 15 March 2016.

Other information about Bluevac BTV8:

The European Commission granted a marketing authorisation valid throughout the EU, for Bluevac BTV8 on 14 April 2011.

For more information about treatment with Bluevac BTV8, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Name Language First published Last updated
Bluevac BTV8 : EPAR - Summary for the public BG = bălgarski 2011-04-29 2018-01-12
Bluevac BTV8 : EPAR - Summary for the public ES = español 2011-04-29 2018-01-12
Bluevac BTV8 : EPAR - Summary for the public CS = čeština 2011-04-29 2018-01-12
Bluevac BTV8 : EPAR - Summary for the public DA = dansk 2011-04-29 2018-01-12
Bluevac BTV8 : EPAR - Summary for the public DE = Deutsch 2011-04-29 2018-01-12
Bluevac BTV8 : EPAR - Summary for the public ET = eesti keel 2011-04-29 2018-01-12
Bluevac BTV8 : EPAR - Summary for the public EL = elliniká 2011-04-29 2018-01-12
Bluevac BTV8 : EPAR - Summary for the public EN = English 2011-04-29 2018-01-12
Bluevac BTV8 : EPAR - Summary for the public FR = français 2011-04-29 2018-01-12
Bluevac BTV8 : EPAR - Summary for the public IT = italiano 2011-04-29 2018-01-12
Bluevac BTV8 : EPAR - Summary for the public LV = latviešu valoda 2011-04-29 2018-01-12
Bluevac BTV8 : EPAR - Summary for the public LT = lietuvių kalba 2011-04-29 2018-01-12
Bluevac BTV8 : EPAR - Summary for the public HU = magyar 2011-04-29 2018-01-12
Bluevac BTV8 : EPAR - Summary for the public MT = Malti 2011-04-29 2018-01-12
Bluevac BTV8 : EPAR - Summary for the public NL = Nederlands 2011-04-29 2018-01-12
Bluevac BTV8 : EPAR - Summary for the public PL = polski 2011-04-29 2018-01-12
Bluevac BTV8 : EPAR - Summary for the public PT = português 2011-04-29 2018-01-12
Bluevac BTV8 : EPAR - Summary for the public RO = română 2011-04-29 2018-01-12
Bluevac BTV8 : EPAR - Summary for the public SK = slovenčina 2011-04-29 2018-01-12
Bluevac BTV8 : EPAR - Summary for the public SL = slovenščina 2011-04-29 2018-01-12
Bluevac BTV8 : EPAR - Summary for the public FI = suomi 2011-04-29 2018-01-12
Bluevac BTV8 : EPAR - Summary for the public SV = svenska 2011-04-29 2018-01-12
Bluevac BTV8 : EPAR - Summary for the public HR = Hrvatski 2011-04-29 2018-01-12

This EPAR was last updated on 12/01/2018 .

Authorisation details

Product details

Product details for Bluevac BTV8
NameBluevac BTV8
Agency product numberEMEA/V/C/000156
Active substance

bluetongue virus inactivated, serotype 8

International non-proprietary name (INN) or common name

bluetongue virus inactivated, serotype 8

Species SheepCattle
Anatomical therapeutic chemical veterinary (ATCvet) codes QI04AA02




Accelerated procedure

Accelerated procedures are intended to speed up access to new medicines of major public-health interest. Eligible products must either responds to unmet medical needs or constitute a significant improvement over the available methods of prevention, diagnosis or treatment of a condition.

Publication details

Publication details for Bluevac BTV8
Marketing-authorisation holder

CZ Veterinaria S.A.

Revision5
Date of issue of marketing authorisation valid throughout the European Union14/04/2011

Contact address:

CZ Veterinaria S.A.
La Relva s/n
36400 Porriño (Pontevedra)
Spain

Product information

Product information

18/07/2016  Bluevac BTV8 -EMEA/V/C/000156 -IAIN/0008

Name Language First published Last updated
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20
Bluevac BTV8 : EPAR - Product Information HR = Hrvatski 2011-04-29 2016-07-20

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
Bluevac BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2011-04-29  
Bluevac BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2011-04-29  
Bluevac BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2011-04-29  
Bluevac BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2011-04-29  
Bluevac BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2011-04-29  
Bluevac BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2011-04-29  
Bluevac BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2011-04-29  
Bluevac BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2011-04-29  
Bluevac BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2011-04-29  
Bluevac BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2011-04-29  
Bluevac BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2011-04-29  
Bluevac BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2011-04-29  
Bluevac BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2011-04-29  
Bluevac BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2011-04-29  
Bluevac BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2011-04-29  
Bluevac BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2011-04-29  
Bluevac BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2011-04-29  
Bluevac BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2011-04-29  
Bluevac BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2011-04-29  
Bluevac BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2011-04-29  

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

Sheep

Active immunisation against bluetongue virus serotype 8 to prevent viraemia and to reduce clinical signs.

Onset of immunity: 20 days after second dose.

Duration of immunity: 1 year after second dose.

Cattle

Active immunisation against bluetongue virus serotype 8 to prevent viraemia.

Onset of immunity: 31 days after second dose.

Duration of immunity: 1 year after second dose.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Bluevac BTV8 : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2013-01-24 2016-07-20

Initial marketing-authorisation documents

Name Language First published Last updated
Bluevac BTV8 : EPAR - Scientific Discussion HR = Hrvatski 2011-04-29  
CVMP summary of positive opinion for Bluevac BTV8 HR = Hrvatski 2011-02-11