BTVPUR Alsap 8

bluetongue virus serotype 8 antigen

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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 BTVPUR AlSap 8?

BTVPUR AlSap 8 is a vaccinethat is available as a suspension for injection. It contains inactivated (killed) bluetongue serotype 8 virus.

What is BTVPUR AlSap 8 used for?

BTVPUR AlSap 8 is used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges. The vaccine is used to prevent viraemia (the presence of viruses in the blood) and reduce the signs of the disease caused by bluetongue virus serotype 8.

The vaccine is given to animals as an injection under the skin. Both sheep and cattle will need a second injection three to four weeks later. The first injection is given at one month of age in animals that have never been exposed to the disease, and at two-and-a-half months if the animal’s mother is already immune to the disease.

How does BTVPUR AlSap 8 work?

BTVPUR AlSap 8 is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. BTVPUR AlSap 8 contains bluetongue viruses that have been inactivated so that they cannot cause the disease. When it is given to sheep and cattle, the animals’ immune system recognises the viruses as ‘foreign’ and makes antibodies against them. In the future, if the animals are exposed to the bluetongue virus their immune systems will be able to produce antibodies more quickly. This will help to protect them against the disease.

BTVPUR AlSap 8 contains bluetongue virus of one type (‘serotype 8’). The vaccine also contains ‘adjuvants’ (aluminium hydroxide and saponin) to enhance the immune response.

How has BTVPUR AlSap 8 been studied?

The safety of the vaccine was studied in a number of laboratory safety studies carried out with BTVPUR AlSap in sheep and cattle using a high dose of the vaccine in animals of the minimum age. Results from a series of laboratory safety trials performed with vaccines of similar composition but of different bluetongue serotypes were also presented in order to extrapolate safety conclusions, as the vaccine was initially intended for use in an emergency situation.

The efficacy of the vaccine in cattle was studied in a laboratory study using the vaccine in cattle from one month of age. Another laboratory study looked at the use of the vaccine in sheep aged three to four months. The duration of protection was also investigated in studies using sheep and cattle and was found to be 12 months for both species.

What benefit has BTVPUR AlSap 8 shown during the studies?

The studies showed that the vaccine is safe for sheep and cattle and that it prevents viraemia and reduces the signs of the disease in animals from one month of age that are infected with bluetongue virus serotype 8.

The studies also demonstrated that the vaccine can be used in pregnant sheep and cows. The effects of maternally derived antibodies were investigated and the vaccine was shown to be effective in animals from 2.5 months of age.

What is the risk associated with BTVPUR AlSap 8?

After vaccination, there can be a small swelling at the injection site lasting up to two weeks. Animals may show a temporary increase in body temperature, usually of no more than 1°C, in the 24 hours after vaccination.

What is the withdrawal period?

After vaccination, there can be a small swelling at the injection site lasting up to two weeks. Animals may show a temporary increase in body temperature, usually of no more than 1°C, in the 24 hours after vaccination.

Why has BTVPUR AlSap 8 been approved?

The CVMP considered that the benefits of BTVPUR AlSap 8 are greater than the risks and recommended that it be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

BTVPUR AlSap 8 was initially authorised under ‘exceptional circumstances’. This means that it was not possible to obtain complete information about BTVPUR AlSap 8 at the time of the initial authorisation. Every year, the European Medicines Agency reviewed additional information according to an agreed timetable on the quality, safety and efficacy of the vaccine. In 2012, the CVMP considered the submitted data to be adequate for the authorisation of BTVPUR AlSap 8 to convert to normal.

Other information about BTVPUR Alsap 8

The European Commission granted a marketing authorisation valid throughout the European Union for BTVPUR AlSap 8 on 17 March 2009. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
BTVPUR Alsap 8 : EPAR - Summary for the public BG = bălgarski 2013-04-19  
BTVPUR Alsap 8 : EPAR - Summary for the public ES = español 2013-04-19  
BTVPUR Alsap 8 : EPAR - Summary for the public CS = čeština 2013-04-19  
BTVPUR Alsap 8 : EPAR - Summary for the public DA = dansk 2013-04-19  
BTVPUR Alsap 8 : EPAR - Summary for the public DE = Deutsch 2013-04-19  
BTVPUR Alsap 8 : EPAR - Summary for the public ET = eesti keel 2013-04-19  
BTVPUR Alsap 8 : EPAR - Summary for the public EL = elliniká 2013-04-19  
BTVPUR Alsap 8 : EPAR - Summary for the public EN = English 2013-04-19  
BTVPUR Alsap 8 : EPAR - Summary for the public FR = français 2013-04-19  
BTVPUR Alsap 8 : EPAR - Summary for the public IT = italiano 2013-04-19  
BTVPUR Alsap 8 : EPAR - Summary for the public LV = latviešu valoda 2013-04-19  
BTVPUR Alsap 8 : EPAR - Summary for the public LT = lietuvių kalba 2013-04-19  
BTVPUR Alsap 8 : EPAR - Summary for the public HU = magyar 2013-04-19  
BTVPUR Alsap 8 : EPAR - Summary for the public MT = Malti 2013-04-19  
BTVPUR Alsap 8 : EPAR - Summary for the public NL = Nederlands 2013-04-19  
BTVPUR Alsap 8 : EPAR - Summary for the public PL = polski 2013-04-19  
BTVPUR Alsap 8 : EPAR - Summary for the public PT = português 2013-04-19  
BTVPUR Alsap 8 : EPAR - Summary for the public RO = română 2013-04-19  
BTVPUR Alsap 8 : EPAR - Summary for the public SK = slovenčina 2013-04-19  
BTVPUR Alsap 8 : EPAR - Summary for the public SL = slovenščina 2013-04-19  
BTVPUR Alsap 8 : EPAR - Summary for the public FI = suomi 2013-04-19  
BTVPUR Alsap 8 : EPAR - Summary for the public SV = svenska 2013-04-19  

This EPAR was last updated on 14/04/2014 .

Authorisation details

Product details

Product details for BTVPUR Alsap 8
NameBTVPUR Alsap 8
Agency product numberEMEA/V/C/000146
Active substance

bluetongue virus serotype 8 antigen

International non-proprietary name (INN) or common name

adjuvanted bluetongue virus vaccine

Species SheepCattle
Anatomical therapeutic chemical veterinary (ATCvet) codeQI02AA08

Publication details

Publication details for BTVPUR Alsap 8
Marketing-authorisation holder

Merial

Revision5
Date of issue of marketing authorisation valid throughout the European Union17/03/2009

Contact address:

Merial
29, avenue Tony Garnier
69007 Lyon
France

Product information

Product information

12/03/2014  BTVPUR Alsap 8 -EMEA/V/C/000146 -R/0010

Name Language First published Last updated
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2014-04-14

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
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09  
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09  
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09  
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09  
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09  
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09  
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09  
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09  
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09  
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09  
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09  
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09  
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09  
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09  
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09  
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09  
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09  
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09  
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09  
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09  
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09  
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09  

Pharmacotherapeutic group

Immunologicals For ovidae; immunologicals for bovidae

Therapeutic indication

Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.
*(below the level of detection by the validated RT-PCR method at 3.14log10 RNA copies/ml, indicating no infectious virus transmission).

Onset of immunity has been demonstrated 3 weeks after the primary vaccination course.

The duration of immunity for cattle and sheep is 1 year after the primary vaccination course.

The duration of immunity is not yet fully established in cattle or sheep, although interim results of ongoing studies demonstrate that the duration is at least 6 months after the primary vaccination course in sheep.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
BTVPUR Alsap 8 : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2010-01-25 2014-04-14
BTVPUR Alsap 8-V-C-146-S-08 : EPAR - Assessment Report - Variation SV = svenska 2012-10-10  

Initial marketing-authorisation documents