BTVPUR AlSap 2-4

bluetongue-virus serotype-2 antigen / bluetongue-virus serotype-4 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 2-4?

BTVPUR AlSap 2-4 is a vaccine. It is available as a suspension for injection that contains inactivated (killed) bluetongue serotype 2 and 4 viruses.

What is BTVPUR AlSap 2-4 used for?

BTVPUR ALSap 2-4 is used in sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges. The virus exists in several forms (serotypes) throughout the world; the types used in BTVPUR Alsap 2-4 are serotypes 2 and 4. The vaccine is used to prevent viraemia (the presence of viruses in the blood) and reduce the signs of the disease.

The vaccine is given to young animals as an injection under the skin. The injection is given from one month of age in animals that have never been exposed to the disease, and from two-and-a-half months if the animal is likely to have inherited antibodies against the virus from a mother that is already immune to the disease. Protection starts three and five weeks after the injection for serotype 4 and serotype 2, respectively. Protection lasts for one year.

How does BTVPUR AlSap 2-4 work?

BTVPUR ALSap 2-4 is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. BTVPUR AlSap 2-4 contains bluetongue viruses that have been inactivated so that they cannot cause the disease. When it is given to sheep, the animals’ immune systems recognise the viruses as ‘foreign’ and make antibodies against them. In the future, if the animals are exposed to bluetongue virus, the immune system will be able to produce antibodies more quickly. This will help to protect against the disease.

BTVPUR AlSap 2-4 contains bluetongue viruses of two types (serotypes 2 and 4). The vaccine also contains ‘adjuvants’ (aluminium hydroxide and saponin) to stimulate a better response.

How has BTVPUR AlSap 2-4 been studied?

The safety of the vaccine was studied in an overdose laboratory safety study carried out with BTVPUR AlSap 2-4 in sheep. Results also from a series of laboratory safety trials performed with vaccines of similar composition but including only one of the two serotypes of BTVPUR AlSap 2-4 or different bluetongue serotypes were presented in order to extrapolate safety conclusions.

The effectiveness of the vaccine in sheep was studied in a pivotal laboratory trial using the vaccine in sheep from a young age. Two more laboratory studies with BTVPUR AlSap 2-4 were presented to support the efficacy of the vaccine. The company also presented results from a series of trials conducted with vaccines of similar composition but including only one of the two serotypes of BTVPUR AlSap 2-4 in order to extrapolate further efficacy conclusions.

Two further studies were conducted to determine the period of protection of the monovalent vaccines each containing either bluetongue virus serotype 2 or 4 respectively. In both studies lambs were exposed to either bluetonguevirus serotype 2 or bluetonguevirus serotype 4, 12 months after vaccination.

What benefit has BTVPUR AlSap 2-4 shown during the studies?

The safety and effectiveness studies showed that the vaccine is safe for sheep and that it reduces the signs of the disease and prevents viraemia in animals from one month of age that are infected with bluetongue virus serotypes 2 and 4. The studies also showed that the vaccine can be used in pregnant and lactating sheep.

The studies on the monovalent vaccines containing bluetongue virus serotypes 2 or 4 showed that the period of protection is 12 months for both serotypes.

What is the risk associated with BTVPUR AlSap 2-4?

Vaccination may be followed by a small local swelling at the injection site (up to 24 cm2) for a short period (up to two weeks).

Animals may show a slight rise in body temperature, normally no more than 1.1°C on average, in the 24 hours following vaccination.

What is the withdrawal period?

The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat or milk used for human consumption. The withdrawal period for BTVPUR Alsap 2-4 for meat and milk for sheep is zero days.

Why has BTVPUR AlSap 2-4 been approved?

The CVMP concluded that the benefits of BTVPUR AlSap 2-4 exceed the risks for active immunisation of sheep to prevent infection, viraemia and clinical signs caused by the bluetongue virus serotypes 2 and 4, and recommended that BTVPUR AlSap 2-4 be given marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

BTVPUR AlSap 2-4 was initially authorised under ‘exceptional circumstances’. This means that it was not possible to obtain complete information about BTVPUR AlSap 2-4 at the time of the initial authorisation. The European Medicines Agency (EMA) reviewed additional information according to an agreed timetable on the quality, safety and efficacy of the vaccine. In 2014 the CVMP considered that the submitted data were adequate for the authorisation of BTVPUR Alsap 2-4 to convert to a normal status.

Other information about BTVPUR AlSap 2-4:

The European Commission granted a marketing authorisation valid throughout the EU for BTVPUR AlSap 2-4 on 5 November 2010. Information on the prescription status of this product may be found on the label/outer package.

Name Language First published Last updated
BTVPUR AlSap 2-4 : EPAR - Summary for the public BG = bălgarski 2010-11-09 2014-06-13
BTVPUR AlSap 2-4 : EPAR - Summary for the public ES = español 2010-11-09 2014-06-13
BTVPUR AlSap 2-4 : EPAR - Summary for the public CS = čeština 2010-11-09 2014-06-13
BTVPUR AlSap 2-4 : EPAR - Summary for the public DA = dansk 2010-11-09 2014-06-13
BTVPUR AlSap 2-4 : EPAR - Summary for the public DE = Deutsch 2010-11-09 2014-06-13
BTVPUR AlSap 2-4 : EPAR - Summary for the public ET = eesti keel 2010-11-09 2014-06-13
BTVPUR AlSap 2-4 : EPAR - Summary for the public EL = elliniká 2010-11-09 2014-06-13
BTVPUR AlSap 2-4 : EPAR - Summary for the public EN = English 2010-11-09 2014-06-13
BTVPUR AlSap 2-4 : EPAR - Summary for the public FR = français 2010-11-09 2014-06-13
BTVPUR AlSap 2-4 : EPAR - Summary for the public IT = italiano 2010-11-09 2014-06-13
BTVPUR AlSap 2-4 : EPAR - Summary for the public LV = latviešu valoda 2010-11-09 2014-06-13
BTVPUR AlSap 2-4 : EPAR - Summary for the public LT = lietuvių kalba 2010-11-09 2014-06-13
BTVPUR AlSap 2-4 : EPAR - Summary for the public HU = magyar 2010-11-09 2014-06-13
BTVPUR AlSap 2-4 : EPAR - Summary for the public MT = Malti 2010-11-09 2014-06-13
BTVPUR AlSap 2-4 : EPAR - Summary for the public NL = Nederlands 2010-11-09 2014-06-13
BTVPUR AlSap 2-4 : EPAR - Summary for the public PL = polski 2010-11-09 2014-06-13
BTVPUR AlSap 2-4 : EPAR - Summary for the public PT = português 2010-11-09 2014-06-13
BTVPUR AlSap 2-4 : EPAR - Summary for the public RO = română 2010-11-09 2014-06-13
BTVPUR AlSap 2-4 : EPAR - Summary for the public SK = slovenčina 2010-11-09 2014-06-13
BTVPUR AlSap 2-4 : EPAR - Summary for the public SL = slovenščina 2010-11-09 2014-06-13
BTVPUR AlSap 2-4 : EPAR - Summary for the public FI = suomi 2010-11-09 2014-06-13
BTVPUR AlSap 2-4 : EPAR - Summary for the public SV = svenska 2010-11-09 2014-06-13

This EPAR was last updated on 13/08/2015 .

Authorisation details

Product details

Product details for BTVPUR AlSap 2-4
NameBTVPUR AlSap 2-4
Agency product numberEMEA/V/C/000139
Active substance

bluetongue-virus serotype-2 antigen / bluetongue-virus serotype-4 antigen

International non-proprietary name (INN) or common name

inactivated adjuvanted vaccine against bluetongue virus serotype 2 and 4 infections

Species Sheep
Anatomical therapeutic chemical veterinary (ATCvet) codeQI04AA02

Publication details

Publication details for BTVPUR AlSap 2-4
Marketing-authorisation holder

Mérial

Revision3
Date of issue of marketing authorisation valid throughout the European Union05/11/2010

Contact address:

Mérial
29 avenue Tony Garnier
BP 7123
69007 Lyon Cedex 07
France

Product information

Product information

31/07/2015  BTVPUR AlSap 2-4 -EMEA/V/C/000139 -R/0006

Name Language First published Last updated
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13
BTVPUR AlSap 2-4 : EPAR - Product Information SV = svenska 2010-11-09 2015-08-13

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 2-4 : EPAR - All Authorised presentations SV = svenska 2010-11-09  
BTVPUR AlSap 2-4 : EPAR - All Authorised presentations SV = svenska 2010-11-09  
BTVPUR AlSap 2-4 : EPAR - All Authorised presentations SV = svenska 2010-11-09  
BTVPUR AlSap 2-4 : EPAR - All Authorised presentations SV = svenska 2010-11-09  
BTVPUR AlSap 2-4 : EPAR - All Authorised presentations SV = svenska 2010-11-09  
BTVPUR AlSap 2-4 : EPAR - All Authorised presentations SV = svenska 2010-11-09  
BTVPUR AlSap 2-4 : EPAR - All Authorised presentations SV = svenska 2010-11-09  
BTVPUR AlSap 2-4 : EPAR - All Authorised presentations SV = svenska 2010-11-09  
BTVPUR AlSap 2-4 : EPAR - All Authorised presentations SV = svenska 2010-11-09  
BTVPUR AlSap 2-4 : EPAR - All Authorised presentations SV = svenska 2010-11-09  
BTVPUR AlSap 2-4 : EPAR - All Authorised presentations SV = svenska 2010-11-09  
BTVPUR AlSap 2-4 : EPAR - All Authorised presentations SV = svenska 2010-11-09  
BTVPUR AlSap 2-4 : EPAR - All Authorised presentations SV = svenska 2010-11-09  
BTVPUR AlSap 2-4 : EPAR - All Authorised presentations SV = svenska 2010-11-09  
BTVPUR AlSap 2-4 : EPAR - All Authorised presentations SV = svenska 2010-11-09  
BTVPUR AlSap 2-4 : EPAR - All Authorised presentations SV = svenska 2010-11-09  
BTVPUR AlSap 2-4 : EPAR - All Authorised presentations SV = svenska 2010-11-09  
BTVPUR AlSap 2-4 : EPAR - All Authorised presentations SV = svenska 2010-11-09  
BTVPUR AlSap 2-4 : EPAR - All Authorised presentations SV = svenska 2010-11-09  
BTVPUR AlSap 2-4 : EPAR - All Authorised presentations SV = svenska 2010-11-09  

Pharmacotherapeutic group

Immunologicals for ovidae sheep, inactivated viral vaccines bluetongue virus

Therapeutic indication

Active immunisation of sheep to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 2 and 4.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
BTVPUR AlSap 2-4 : EPAR - Procedural steps taken before authorisation SV = svenska 2010-11-09  
BTVPUR AlSap 2-4 : EPAR - Scientific Discussion SV = svenska 2010-11-09  
CVMP summary of positive opinion for BTVPUR AlSap 2-4 SV = svenska 2010-07-16  

Authorised

This medicine is approved for use in the European Union

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