Zulvac SBV

Inactivated Schmallenberg virus, strain BH80/11-4

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This is a summary of the European public assessment report (EPAR) for Zulvac SBV. 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 Zulvac SBV.

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

What is Zulvac SBV?

Zulvac SBV is a veterinary vaccine used to protect cattle and sheep from 3.5 months of age against Schmallenberg virus by reducing viraemia (presence of virus in the blood). Schmallenberg virus is transmitted by midges and causes stillbirths and birth defects in cattle and sheep.

Zulvac SBV contains the active substance inactivated (killed) Schmallenberg virus strain BH80/11-4.

What is Zulvac SBV used for?

Zulvac SBV is available as a suspension for injection and can only be obtained with a prescription. The vaccine is given to cattle as two injections of 2 ml into the neck muscle three weeks apart and to sheep as a single injection of 1 ml under the skin behind the elbow. For female sheep vaccination should be at least two weeks before breeding to reduce viraemia (virus in the blood) and infection of the embryo during the first trimester of pregnancy.

For booster vaccination in cattle two injections of 2 ml should be given three weeks apart every 12 months. For booster vaccination in non-breeding sheep a single injection of 1 ml should be given every six months whilst in female breeding sheep a single injection of 1 ml should be given at least two weeks before breeding.

In cattle protection starts two weeks after vaccination and lasts 12 months. In sheep protection starts three weeks after vaccination and lasts six months.

How does Zulvac SBV work?

Zulvac SBV is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Zulvac SBV contains Schmallenberg virus that has been inactivated so that it cannot cause disease. When it is given to cattle or sheep, the animals’ immune system recognises the virus as foreign and makes antibodies against it. In the future if the animals are exposed to Schmallenberg virus, the immune system will be able to produce antibodies more quickly. This will help protect them against the disease. The vaccine also contains ‘adjuvants’ (aluminium hydroxide and saponin) to enhance the immune response.

What benefits of Zulvac SBV have been shown in studies?

The effectiveness of Zulvac SBV has been investigated in laboratory studies in cattle and sheep. The animals were vaccinated according to the vaccination schedule and were then exposed to the Schmallenberg virus. The main measure of effectiveness was absence of viraemia following exposure to the virus.The studies showed that Zulvac SBV protects cattle two weeks and sheep three weeks after vaccination. In pregnant ewes vaccination reduced viraemia and infection of the embryo.

What are the risks associated with Zulvac SBV?

In cattle, an increase in body temperature of up to 1.5°C during the 48 hours after vaccination and the appearance of small lumps of up to 0.7 cm in diameter at the vaccination site that resolve within 10 days are very common (seen in more than 1 animal in 10).

In sheep more than one in ten animals may have an increase in body temperature of up to 1.5 °C during the 24 hours after vaccination. More than one in ten animals may show swellings or lumps of up to 8 cm in diameter under the skin at the injection site, and swellings less than 2 cm in diameter may last for at least 47 days.

In pregnant ewes more than one in ten animals may have an increase in body temperature of up to 0.8 °C during 4 hours after vaccination. More than one in ten animals may show swellings or lumps of up to 8 cm in diameter under the skin at the injection site, which may last for at least 97 days as granules less than 0.5 cm in diameter.

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

In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.

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.

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

Why has Zulvac SBV been approved?

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

Other information about Zulvac SBV:

The European Commission granted a marketing authorisation valid throughout the EU for Zulvac SBV on 6 February 2015.

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

Name Language First published Last updated
Zulvac SBV : EPAR - Summary for the public BG = bălgarski 2015-03-02 2015-01-07
Zulvac SBV : EPAR - Summary for the public ES = español 2015-03-02 2015-01-07
Zulvac SBV : EPAR - Summary for the public CS = čeština 2015-03-02 2015-01-07
Zulvac SBV : EPAR - Summary for the public DA = dansk 2015-03-02 2015-01-07
Zulvac SBV : EPAR - Summary for the public DE = Deutsch 2015-03-02 2015-01-07
Zulvac SBV : EPAR - Summary for the public ET = eesti keel 2015-03-02 2015-01-07
Zulvac SBV : EPAR - Summary for the public EL = elliniká 2015-03-02 2015-01-07
Zulvac SBV : EPAR - Summary for the public EN = English 2015-03-02 2015-01-07
Zulvac SBV : EPAR - Summary for the public FR = français 2015-03-02 2015-01-07
Zulvac SBV : EPAR - Summary for the public IT = italiano 2015-03-02 2015-01-07
Zulvac SBV : EPAR - Summary for the public LV = latviešu valoda 2015-03-02 2015-01-07
Zulvac SBV : EPAR - Summary for the public LT = lietuvių kalba 2015-03-02 2015-01-07
Zulvac SBV : EPAR - Summary for the public HU = magyar 2015-03-02 2015-01-07
Zulvac SBV : EPAR - Summary for the public MT = Malti 2015-03-02 2015-01-07
Zulvac SBV : EPAR - Summary for the public NL = Nederlands 2015-03-02 2015-01-07
Zulvac SBV : EPAR - Summary for the public PL = polski 2015-03-02 2015-01-07
Zulvac SBV : EPAR - Summary for the public PT = português 2015-03-02 2015-01-07
Zulvac SBV : EPAR - Summary for the public RO = română 2015-03-02 2015-01-07
Zulvac SBV : EPAR - Summary for the public SK = slovenčina 2015-03-02 2015-01-07
Zulvac SBV : EPAR - Summary for the public SL = slovenščina 2015-03-02 2015-01-07
Zulvac SBV : EPAR - Summary for the public FI = suomi 2015-03-02 2015-01-07
Zulvac SBV : EPAR - Summary for the public SV = svenska 2015-03-02 2015-01-07
Zulvac SBV : EPAR - Summary for the public HR = Hrvatski 2015-03-02 2015-01-07

This EPAR was last updated on 11/04/2017 .

Authorisation details

Product details

Product details for Zulvac SBV
NameZulvac SBV
Agency product numberEMEA/V/C/002781
Active substance

Inactivated Schmallenberg virus, strain BH80/11-4

International non-proprietary name (INN) or common name

Inactivated Schmallenberg virus, strain BH80/11-4

Species SheepCattle
Anatomical therapeutic chemical veterinary (ATCvet) codes QI02AA


Publication details

Publication details for Zulvac SBV
Marketing-authorisation holder

Zoetis Belgium SA

Revision2
Date of issue of marketing authorisation valid throughout the European Union06/02/2015

Contact address:

Zoetis Belgium SA
Rue Laid Burnait, 1
1348 Louvain-la-Neuve
Belgium

Product information

Product information

23/03/2017  Zulvac SBV -EMEA/V/C/002781 -IG/0747

Name Language First published Last updated
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11
Zulvac SBV : EPAR - Product Information HR = Hrvatski 2015-03-02 2017-04-11

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
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  
Zulvac SBV : EPAR - All Authorised presentations HR = Hrvatski 2015-03-02  

Pharmacotherapeutic group

Immunologicals for bovidae, inactivated viral vaccines for cattle

Therapeutic indication

For active immunisation of cattle and sheep from 3.5 months of age to prevent viraemia associated with infection by Schmallenberg virus.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Zulvac SBV : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2016-01-07 2017-04-11
Zulvac SBV-V-C-2781-II-0002-G : EPAR - Assessment Report - Variation HR = Hrvatski 2016-01-07  

Initial marketing-authorisation documents

Name Language First published Last updated
Zulvac SBV : EPAR - Public assessment report HR = Hrvatski 2015-03-02  
CVMP summary of positive opinion for Zulvac SBV HR = Hrvatski 2014-12-12